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Registration of Pharmaceutical Manufacturing Facilities with MOHAP in UAE

In the United Arab Emirates (UAE), the Ministry of Health and Prevention (MOHAP) plays a crucial role in regulating pharmaceutical manufacturing facilities to ensure compliance with stringent standards and regulations. This comprehensive guide provides an overview of the service process, requirements, fees, and post-approval obligations associated with registering pharmaceutical manufacturing facilities with MOHAP.

Registration Pharmaceutical facilities MoHAP UAE

Registration Process for Pharmaceutical Facilities with MoHAP in UAE

Non-citizens can own pharmaceutical establishments with approval from the local authority regarding the percentage of foreign ownership. To obtain final approval for the license, the facility should appoint licensed experienced pharmacists as technical, quality, and production managers. The process of obtaining licensing for pharmaceutical manufacturing facilities in the UAE involves several sequential steps, ensuring compliance with regulatory standards and requirements. Here's an overview of the key stages –

Initial Approval of the Manufacturing Facility

To initiate the licensing process, the facility must obtain initial approval from the Ministry of Health and Prevention (MOHAP). This involves submitting various documents, including the memorandum and articles of association, project feasibility study, partnership contract, and personal identification documents of the partners. Security clearance for each partner is also required, which entails filling an 'introductory statement' and providing relevant identification documents. The approval granted by the Pharmaceutical Licensing Committee is valid for six months, extendable upon request.

Manufacturing Facility Construction and Preparation

Upon receiving initial approval, the facility proceeds with the construction and preparation phase. Detailed engineering drawings demonstrating material flow, personnel flow, and compliance with good manufacturing practices (GMP) are submitted for approval by the technical committee within the drug department. Once the drawings are approved, additional documents are submitted, preparing the facility for inspection by the drug department for GMP certification.

Final Licensing of the Manufacturing Facility and GMP Certificate Issuance

After successfully completing the construction and preparation stage, the facility appoints technicians and obtains licenses for key positions such as production manager, quality assurance manager, and quality control manager. If the facility is limited to medical equipment production, a biomedical engineer license may replace the pharmacist's license. The final approval is granted upon submission of all required documents, paving the way for the final inspection by the inspection team. Upon satisfactory inspection results and document verification, the final license is issued to the manufacturing facility.

This comprehensive process ensures that pharmaceutical manufacturing facilities in the UAE adhere to stringent regulatory standards and are equipped to produce high-quality pharmaceutical products in compliance with GMP guidelines.

Process for registration of Pharmaceutical Facilities with MoHAP in UAE

  • Login and Application: Begin by logging in to the MOHAP website or smart app using UAEPASS to apply for the service. Submit an application to obtain pre-licensing approval for a pharmaceutical facility.

  • Initial Approval: Upon submission, an approval will be issued for the local citizen owner. Proceed to submit a request for an initial inspection and pay the inspection fee.

  • Final Approval: After approval of the initial inspection, submit a request for the final inspection and pay the fee. Once the final inspection is approved, submit the final approval request with the remaining documents.

  • License Issuance: If the application is approved, pay the license fee. The license is then issued electronically and sent via email or can be downloaded from the website.

Timelines for registration of Pharmaceutical Facilities with MoHAP in UAE

When initiating the licensing process for pharmaceutical and medical device manufacturing facilities, several critical steps must be followed. Here's a breakdown of the timeline for each stage:

Registration of Pharmaceutical facilities in MoHAP UAE

Fees for registration of Pharmaceutical Facilities with MoHAP in UAE

The UAE Ministry of Health and Prevention (MOHAP) imposes varying fees at different stages of the facility approval process. Payments are required at different intervals throughout the approval process.

Registration of Pharmaceutical facilities in MoHAP UAE

Additional Approvals Required for Pharmaceutical and Medical Device Manufacturing Facilities

In addition to obtaining licensing and compliance certification from the Ministry of Health and Prevention (MOHAP), pharmaceutical and medical device manufacturing facilities must also secure approvals from various other government agencies. These approvals are crucial for ensuring comprehensive compliance and operational readiness. Here are the key agencies involved and their respective roles:

  • Ministry of Interior: Responsible for granting approval for the Introductory Statement of the Subjected Facility's Owner(s), a vital step in establishing the ownership structure of the facility.

  • Departments of Economic Development: Involved in the registration of the trade name and issuance of the trade license, essential for conducting business operations legally.

  • Ministry of Health and Prevention: Manages the licensing of medical professionals and pharmacists, ensuring that qualified personnel are employed in key roles within the facility.

  • Civil Defense: Issues the Civil Defense Certificate, confirming compliance with fire prevention and firefighting requirements, thereby ensuring the safety and security of the facility.

  • Ministry of Climate Change and Environment (MOCCAE): Responsible for issuing the Environmental Compliance Certificate, which verifies adherence to environmental regulations and standards, promoting sustainable practices in manufacturing operations.

Collaboration with these government agencies is integral to obtaining the necessary approvals and ensuring full compliance with regulatory requirements for pharmaceutical and medical device manufacturing facilities in the UAE.

Change in location of Pharmaceutical Facilities with MoHAP in UAE

Moving a pharmaceutical facility to a new location entails several steps to ensure compliance and seamless transition. The old facility must hold a valid license throughout the relocation process.

Required Documents for change in location -

  • Initial Approval: Memorandum, feasibility study, partnership contract, passports, ID cards, photos, security clearances.

  • Construction and Preparation: Detailed engineering drawings, technical specifications, appointment of technicians.

  • Final Licensing: Pharmacists' licenses, lease agreement, trade license, civil defense certificate.

Process for change in location of Pharmaceutical Manufacturing Facility -

  • Application Submission: Access the facility's account on the Ministry of Health and Prevention (MOHAP) website or smart app using the UAE PASS. Complete the application and pay the required fee.

  • Inspection and initial approval: MOHAP's inspection team conducts an initial inspection of the proposed new location. Upon satisfactory inspection results, an initial approval and No Objection Certificate (NOC) are issued to relevant government entities like the municipality and economic department.

  • Final Approval Process: The manufacturer must submit remaining documents necessary for final approval. MOHAP's staff will conduct a final site inspection to ensure compliance with specifications.

  • License Acquisition: The customer pays the final fee required for license acquisition.

Registration of Pharmaceutical facilities in MoHAP UAE

Document Requirements for change in location of Pharmaceutical Manufacturing Facility

Registration of Pharmaceutical facilities in MoHAP UAE

Navigating the relocation process with MOHAP ensures adherence to regulations and standards, facilitating a smooth transition for pharmaceutical facilities in the UAE.

Renewal of Pharmaceutical Manufacturing Facility in the UAE

Renewing the license for pharmaceutical manufacturing facilities is a vital process to ensure continued compliance with regulations and standards set by the Ministry of Health and Prevention (MOHAP) in the UAE. Renewal services are facilitated through customer happiness centers, ensuring convenience and efficiency for facility owners. The factory license must be renewed annually, contingent upon adherence to good manufacturing practices (GMP) as verified by inspection teams. Facility owners can submit an official request to renew GMP certificates issued by MOHAP two months before the license expiry date to ensure timely completion. Renewal dates are not linked to inspection visits. Failure to renew the license before expiry may result in legal actions. Corrective measures must be taken based on feedback from inspection teams regarding GMP.

Ensuring timely renewal of pharmaceutical facility licenses is essential to maintain compliance with regulations and uphold standards of quality and safety in pharmaceutical production.

Navigating the registration process for pharmaceutical manufacturing facilities with MOHAP is a complex endeavor that requires meticulous planning, documentation, and adherence to regulatory guidelines. However, with expert guidance and support from regulatory compliance specialists like Artixio, pharmaceutical manufacturers can streamline the process and ensure compliance with MOHAP regulations.

Contact us today to learn more about how Artixio can assist you in achieving regulatory compliance and market success in the UAE.

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